(1)

On 26 February 2011, the United Nations Security Council (‘UNSC’) adopted United Nations Security Council Resolution (UNSCR) 1970 (2011), thereby imposing an arms embargo on Libya.

(2)

The UNSC in UNSCR 2292 (2016) authorised States acting nationally or through regional organisations to inspect on the high seas off the coast of Libya vessels which they have reasonable grounds to believe these vessels are carrying arms or related materiel to or from Libya, directly or indirectly, in violation of the United Nations arms embargo on Libya and decided that States, upon discovery during such inspections of items prohibited by the arms embargo on Libya, are to seize and dispose of such items.

(3)

Council Decision (CFSP) 2020/472 (2) provides that the core task of the Union naval operation EUNAVFOR MED IRINI is to contribute to the implementation of the United Nations arms embargo on Libya.

(4)

For that purpose, Article 2(3) of Decision (CFSP) 2020/472 provides that, in accordance with the relevant United Nations Security Council Resolutions, such as UNSCR 1970 (2011) and UNSCR 2473 (2019), and in particular UNSCR 2292 (2016), as required, EUNAVFOR MED IRINI is to carry out, within the agreed Area of Operation on the high seas off the coast of Libya, inspections of vessels bound to or from Libya where there are reasonable grounds to believe that such vessels are carrying arms or related materiel to or from Libya, directly or indirectly, in violation of the arms embargo on Libya, and that EUNAVFOR MED IRINI is to take relevant action to seize and dispose of such items.

(5)

Furthermore, Article 2(5) of Decision (CFSP) 2020/472 provides that, in view of the exceptional operational requirements, and upon invitation from a Member State, EUNAVFOR MED IRINI may divert vessels to ports of that Member State and dispose of arms and related materiel which it has seized, including by storage, destruction or transfer to a Member State or to a third party. It also provides that disposal of seized arms and related materiel may be achieved with the assistance of a Member State, which is to undertake to complete as swiftly as possible the procedures required to allow for the disposal of the seized items, within the framework of applicable law and procedures.

(6)

Council Decision (CFSP) 2023/1439 (3) introduces a provision in Decision (CFSP) 2015/1333 to the effect that such a Member State is required to take the necessary measures to facilitate the disposal, on behalf of EUNAVFOR MED IRINI, of arms and related material seized by EUNAVFOR MED IRINI on the high seas in accordance with its mandate.

(7)

With a view to ensuring the uniform application of that provision in all Member States, regulatory action at the level of the Union is necessary.

(8)

Council Regulation (EU) 2016/44 (4) gives effect to Decision (CFSP) 2015/1333. Regulation (EU) 2016/44 should therefore be amended accordingly,

(1)

Part 1, section 1.1.3, of Annex VI to Regulation (EC) No 1272/2008 contains the list of notes which may be assigned to one or more harmonised classification and labelling entries and relate to the identification, classification and labelling of substances as well as the classification and labelling of mixtures.

(2)

In its opinion of 11 June 2020 concerning 2-ethylhexanoic acid and its salts (2), the Committee for Risk Assessment (RAC) under the European Chemicals Agency recommended to add a new note to Part 1, section 1.1.3.1, of Annex VI to Regulation (EC) No 1272/2008, to clarify that the classification covering a group of substances in the same entry is only based on the hazardous properties of that part of the substance which is common to all substances in that entry. According to RAC, for the non-common parts of a substance, it is necessary to assess if their hazardous properties may warrant a more severe classification (higher category) or a broader classification (including additional differentiation, target organs and/or hazard statements) for the same hazard class. A new note X should therefore be added to Part 1, section 1.1.3.1, of Annex VI to Regulation (EC) No 1272/2008. As that note is likely to be assigned to other substances with the same properties in the future, it should be worded in such way that it is not limited to that specific entry.

(3)

The RAC’s opinion of 20 September 2019 concerning boric acid, diboron trioxide, tetraboron disodium heptaoxide hydrate, disodium tetraborate anhydrous, orthoboric acid sodium salt, disodium tetraborate decahydrate and disodium tetraborate pentahydrate (3) as well as the RAC’s opinion of 11 June 2020 concerning 2-ethylhexanoic acid and its salts, described scientific evidence that the reproductive toxicity of each of these substance groups is due to a molecular entity common to all members of the respective group. When considering proposals for harmonised classification of certain boron compounds and of 2-ethylhexanoic acid and its salts, Member State experts consulted in the CARACAL expert group (Competent Authorities for Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and Classification, Labelling and Packaging (CLP)) requested to add new notes in Part 1, section 1.1.3.2, of Annex VI to Regulation (EC) No 1272/2008. According to the discussion in the CARACAL expert group, these notes are necessary to allow a more accurate identification of the hazard of mixtures, which contain several substances belonging to the same ‘group entry’. The principle of additivity should apply to substances whose hazard is due to the presence or formation of a common molecular entity. As a consequence, it is necessary to take account of the contribution of these substances to the overall hazardous property of the mixture in proportion to their concentration, by comparing the applicable generic or specific concentration limit with the sum of the concentrations of the substances present. Therefore, two new notes, note 11 and 12, should be added to Part 1, section 1.1.3.2, of Annex VI to Regulation (EC) No 1272/2008. As note 11 should be assigned to boric acid and its salts, and other boric compounds releasing boric acid/borate, in view of the specificity of the concerned entries, it should be worded in such way that it is specific for those entries. As note 12 is likely to be assigned in the future to substances other than 2-ethylhexanoic acid and its salts, it should be worded in such way that it is not limited to that specific entry.

(4)

Regulation (EC) No 1272/2008 should therefore be amended accordingly,

(1)

Part 3, Table 3, of Annex VI to Regulation (EC) No 1272/2008 contains a list of harmonised classification and labelling of hazardous substances based on the criteria set out in Parts 2 to 5 of Annex I to that Regulation.

(2)

Proposals to introduce harmonised classification and labelling of certain substances and to update or delete the harmonised classification and labelling of certain other substances have been submitted to the European Chemicals Agency (the ‘Agency’) pursuant to Article 37 of Regulation (EC) No 1272/2008. The Committee for Risk Assessment of the Agency (the ‘RAC’) adopted opinions on those proposals, after having taken account of the comments received from the parties concerned.

(3)

The RAC’s opinion of 20 September 2019 concerning boric acid, diboron trioxide, tetraboron disodium heptaoxide hydrate, disodium tetraborate anhydrous, orthoboric acid sodium salt, disodium tetraborate decahydrate and disodium tetraborate pentahydrate (2), as well as the RAC’s opinion of 11 June 2020 concerning 2-ethylhexanoic acid and its salts (3), described scientific evidence indicating that the reproductive toxicity of each of those substance groups is due to a molecular entity common to all members of a substance group. Member State experts consulted in the Commission expert group CARACAL (Competent Authorities for Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and Classification, Labelling and Packaging (CLP)) therefore requested the addition of notes to the entries related to the substance groups referred to in those RAC opinions of 2019 and 2020, in order to address the situation in which several substances belonging to one of those groups are present together in a mixture and to provide that the applicable concentration limit for classification of the mixture is to be compared with the sum of the concentrations of those substances. Those notes were added to Part 1, section 1.1.3.2, of Annex VI to Regulation (EC) No 1272/2008 by Commission Delegated Regulation (EU) 2023/1434 of 25 April 2023 amending, for the purposes of its adaptation to technical and scientific progress, Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures as regards the addition of notes to Part 1, section 1.1.3, of Annex VI (4), as note 11 and note 12. It is therefore appropriate to add a reference to note 11 to the entries for boric acid, diboron trioxide, tetraboron disodium heptaoxide hydrate, disodium tetraborate anhydrous, orthoboric acid sodium salt, disodium tetraborate decahydrate and disodium tetraborate pentahydrate and a reference to note 12 to the entry for 2-ethylhexanoic acid and its salts.

(4)

In its opinion of 11 June 2020 concerning 2-ethylhexanoic acid and its salts, the RAC recommended adding a note to this entry, in order to address the possibility that, while the entry for this group of substances is based on the toxic properties of a common part of those substances, another, substance-specific, part of the substances may warrant classification in a higher category or classification with a broader scope, e.g. including additional differentiation, target organs and/or hazard statements, for certain substances in the entry. Such note was added to Part 1, section 1.1.3.1, of Annex VI to Regulation (EC) No 1272/2008 by Delegated Regulation (EU) 2023/1434 as note X. It is therefore appropriate to add a reference to note X to the entry concerning 2-ethylhexanoic acid and its salts.

(5)

Member State experts consulted in the CARACAL expert group suggested that the current note A should be applicable to 2-ethylhexanoic acid and its salts. Note A prescribes that for substances covered by an entry with a general description, such as ‘…compounds’ or ‘…salts’, the supplier is required to state on the label the correct name. As the entry for 2-ethylhexanoic acid and its salts bears such a general description, a reference to note A should be added to the entry.

(6)

As Delegated Regulation (EU) 2023/1434 was adopted on 25 April 2023, the notes included in that Regulation could not be inserted in Table 3 of Annex VI at the time of the adoption of Commission Delegated Regulation (EU) 2021/849 (5) and Commission Delegated Regulation (EU) 2022/692 (6) which added the respective entries to Table 3 of Annex VI to Regulation (EC) No 1272/2008. It is therefore necessary to update the entries concerning boric acid; diboron trioxide; tetraboron disodium heptaoxide hydrate; disodium tetraborate anhydrous; orthoboric acid sodium salt; disodium tetraborate decahydrate; disodium tetraborate pentahydrate, by adding reference to note 11 to each of them. It is also necessary to update entry concerning 2-ethylhexanoic acid and its salts by adding a reference to note 12 and note X to that entry.

(7)

Regulation (EC) No 1272/2008 should therefore be amended accordingly.

(8)

Compliance with the revised harmonised classifications should not be required immediately as suppliers need some time to adapt the labelling and packaging of substances and mixtures to the revised harmonised classifications and to sell existing stocks of substances and mixtures. That period of time would also allow suppliers to take the actions required to ensure compliance with other requirements set out in Regulation (EC) No 1272/2008, as amended by this Regulation. Suppliers should, however, have the possibility to apply the revised harmonised classifications, and to adapt the labelling and packaging accordingly, on a voluntary basis as from the entry into force of this Regulation, to ensure a high level of protection of human health and of the environment and to provide sufficient flexibility to suppliers,

(1)

Commission Directive 2006/75/EC (2) included dimoxystrobin as an active substance in Annex I to Council Directive 91/414/EEC (3).

(2)

According to Article 78(3) of Regulation (EC) No 1107/2009, active substances included in Annex I to Directive 91/414/EEC are deemed to have been approved under Regulation (EC) No 1107/2009 and are listed in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (4).

(3)

The approval of the active substance dimoxystrobin, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 31 January 2024.

(4)

An application for the renewal of the approval of the active substance dimoxystrobin was submitted to Hungary, the rapporteur Member State, and Ireland, the co-rapporteur Member State, in accordance with Article 1 of Commission Implementing Regulation (EU) No 844/2012 (5) within the time period provided for in that Article.

(5)

The applicant submitted the supplementary dossiers required by Article 6 of Implementing Regulation (EU) No 844/2012 to the rapporteur Member State, the co-rapporteur Member State, the Commission and the European Food Safety Authority (‘the Authority’). The application was found to be complete by the rapporteur Member State.

(6)

The rapporteur Member State prepared a draft renewal assessment report in consultation with the co-rapporteur Member State and submitted it to the Authority and the Commission on 1 September 2017. In its draft renewal assessment report, the rapporteur Member State proposed to renew the approval of the active substance dimoxystrobin.

(7)

The Authority made the supplementary summary dossier available to the public. The Authority also circulated the draft renewal assessment report to the applicant and to the Member States for comments and launched a public consultation on it. The Authority forwarded the comments received to the Commission.

(8)

The Authority conducted expert consultations in the areas of mammalian toxicology, environmental fate and behaviour, and ecotoxicology in January and June 2022. As a result of those consultations the Authority identified concerns, in particular in relation to groundwater contamination by toxicologically relevant metabolites of dimoxystrobin.

(9)

On 12 August 2022, in the light of the concern in relation to groundwater contamination identified by the Authority, the Commission requested the Authority to issue a statement containing a summary of its main findings as regards the assessment of the active substance dimoxystrobin in relation to its environmental fate, its behaviour and its ecotoxicology.

(10)

On 11 October 2022, the Authority communicated that statement to the Commission (6).

(11)

In its statement, the Authority confirmed that a critical area of concern exists for all the representative uses of the active substance, in particular a high potential for groundwater contamination by toxicologically relevant metabolites of dimoxystrobin (505M08 and 505M09) in all geoclimatic conditions represented by the groundwater assessment scenarios.

(12)

The Commission presented its draft renewal report regarding dimoxystrobin and a draft of this Regulation to the Standing Committee on Plants, Animals, Food and Feed on 8 December 2022 and on 25 January 2023, respectively.

(13)

The Commission invited the applicant to submit its comments on the statement of the Authority. Furthermore, in accordance with Article 14(1), third subparagraph, of Implementing Regulation (EU) No 844/2012, the Commission invited the applicant to submit comments on the draft renewal report. The applicant submitted its comments, which have been carefully examined.

(14)

Despite the arguments put forward by the applicant, the concerns related to the environmental fate, behaviour and ecotoxicology of dimoxystrobin could not be eliminated.

(15)

Consequently, it has not been established that dimoxystrobin fulfils the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. It is therefore appropriate not to renew the approval of that active substance.

(16)

Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly.

(17)

Commission Implementing Regulation (EU) 2015/408 (7) listed dimoxystrobin as a candidate for substitution. In the light of the non-renewal of the approval of dimoxystrobin that listing is no longer relevant. Accordingly, dimoxystrobin should be deleted from the Annex to Implementing Regulation (EU) 2015/408.

(18)

Member States should be given time to withdraw authorisations for plant protection products containing dimoxystrobin.

(19)

For plant protection products containing dimoxystrobin, where Member States grant a grace period in accordance with Article 46 of Regulation (EC) No 1107/2009, that period should not exceed 12 months from the date of entry into force of this Regulation.

(20)

Commission Implementing Regulation (EU) 2023/115 (8) extended the approval period of dimoxystrobin to 31 January 2024 in order to allow the renewal process to be completed before the expiry of the approval period. However, given that a decision on the non-renewal of the approval has been taken ahead of the expiry of that extended approval period, this Regulation should apply earlier than that date.

(21)

This Regulation does not prevent the submission of another application for the approval of dimoxystrobin pursuant to Article 7 of Regulation (EC) No 1107/2009.

(22)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

(1)

Directive 2011/65/EU requires Member States to ensure that electrical and electronic equipment placed on the market does not contain the hazardous substances listed in Annex II to that Directive. That restriction does not apply to certain exempted applications listed in Annex IV to that Directive.

(2)

The categories of electrical and electronic equipment to which Directive 2011/65/EU applies are listed in Annex I to that Directive.

(3)

Mercury is a restricted substance listed in Annex II to Directive 2011/65/EU.

(4)

On 26 April 2021, the Commission received an application made in accordance with Article 5(3) of Directive 2011/65/EU for an exemption to be listed in Annex IV to that Directive, for mercury in melt pressure transducers for capillary rheometers at temperatures over 300 °C and pressures over 1 000 bar (‘the requested exemption’).

(5)

The used pressure transducer, incorporated in capillary rheometers, consists of electrical components and is an electrical measurement device in the scope of the Directive 2011/65/EU. The capillary rheometers described in the requested exemption fall under category 9 ‘monitoring and control instruments’ of Annex I to Directive 2011/65/EU.

(6)

The evaluation of the exemption application, which included a technical and scientific assessment study (2), concluded that substitution of mercury in melt pressure transducers for capillary rheometers at temperatures over 300 °C and pressures over 1 000 bar are currently scientifically and technically impracticable. The evaluation included stakeholder consultations as required by Article 5(7) of Directive 2011/65/EU.

(7)

One of the relevant conditions specified in Article 5(1), point (a), of Directive 2011/65/EU is met, namely that the elimination and substitution is scientifically or technically impracticable.

(8)

It is, therefore, appropriate to grant the requested exemption by including the applications covered by it in Annex IV to Directive 2011/65/EU with respect to electrical and electronic equipment of category 9.

(9)

In order to comply with future restrictions on mercury-added products under Regulation (EU) 2017/852 of the European Parliament and of the Council (3), it is necessary to limit the validity period of the exemption to 31 December 2025. The period is set in accordance with Article 5(2), first subparagraph of Directive 2011/65/EU.

(10)

Directive 2011/65/EU should therefore be amended accordingly,

(1)

Commission Directives 2003/90/EC (3) and 2003/91/EC (4) aim to ensure that the varieties of agricultural plant species and vegetable species that Member States include in their national catalogues comply with the protocols established by the Community Plant Variety Office (‘CPVO’). In particular, those Directives aim to ensure compliance with the rules concerning the characteristics to be covered as a minimum by the examination and the minimum conditions for examining certain varieties of agricultural plant and vegetable species. For the species not covered by the CPVO protocols those Directives aim to ensure compliance with guidelines of the International Union for Protection of New Varieties of Plants (‘UPOV’).

(2)

The CPVO and UPOV have updated existing protocols, in particular as regards hemp, garlic, kohlrabi, leaf chicory, watermelon and turnip. Those developments should be reflected in Union law.

(3)

Directives 2003/90/EC and 2003/91/EC should therefore be amended accordingly.

(4)

Member States should apply the new rules from 1 January 2024. However, in order not to disrupt official examinations, the following should apply. For varieties that were not yet accepted for inclusion in the Common Catalogue of varieties of agricultural plant or vegetable species, official examinations, which have started prior to 1 January 2024 and are not yet finalised, should continue to be made in accordance with Directive 2003/90/EC or Directive 2003/91/EC as they stood before being amended by this Directive.

(5)

The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

(1)

On 31 July 2015, the Council adopted Decision (CFSP) 2015/1333 (1) concerning restrictive measures in view of the situation in Libya.

(2)

The United Nations Security Council (‘UNSC’) in its Resolution 2292 (2016) authorised States acting nationally or through regional organisations to inspect on the high seas off the coast of Libya vessels which they have reasonable grounds to believe are carrying arms or related materiel to or from Libya, directly or indirectly, in violation of the United Nations arms embargo on Libya and decided that States, upon discovery during such inspections of items prohibited by the arms embargo on Libya, are to seize and dispose of such items.

(3)

Council Decision (CFSP) 2020/472 (2) provides that the core task of the Union naval operation EUNAVFOR MED IRINI is to contribute to the implementation of the United Nations arms embargo on Libya.

(4)

For that purpose, Article 2(3) of Decision (CFSP) 2020/472 provides that, in accordance with the relevant United Nations Security Council Resolutions (‘UNSCRs’), in particular UNSCR 2292 (2016), and as required, EUNAVFOR MED IRINI is to carry out, within the agreed Area of Operation on the high seas off the coast of Libya, inspections of vessels bound to or from Libya where there are reasonable grounds to believe that such vessels are carrying arms or related materiel to or from Libya, directly or indirectly, in violation of the arms embargo on Libya, and that EUNAVFOR MED IRINI is to take relevant action to seize and dispose of such items.

(5)

Furthermore, Article 2(5) of Decision (CFSP) 2020/472 provides that, in view of the exceptional operational requirements, and upon invitation from a Member State, EUNAVFOR MED IRINI may divert vessels to ports of that Member State and dispose of arms and related materiel which it has seized, including by storage, destruction or transfer to a Member State or to a third party. It also provides that disposal of seized arms and related materiel may be achieved with the assistance of a Member State, which is to undertake to complete as swiftly as possible the procedures required to allow for the disposal of the seized items, within the framework of applicable law and procedures.

(6)

Relevant provisions should therefore be introduced in order to provide that such a Member State is required to take the necessary measures to facilitate the disposal, on behalf of EUNAVFOR MED IRINI, of arms and related material seized by EUNAVFOR MED IRINI on the high seas in accordance with its mandate.

(7)

Decision (CFSP) 2015/1333 should therefore be amended accordingly,

(1)

Council Decision (CFSP) 2021/509 (1) establishes the European Peace Facility (EPF) for the financing by Member States of Union actions under the common foreign and security policy (CFSP) to preserve peace, prevent conflicts and strengthen international security pursuant to Article 21(2), point (c), of the Treaty. In particular, pursuant to Article 1(2) of Decision (CFSP) 2021/509, the EPF is to be used for the financing of assistance measures such as actions to strengthen the capacities of third States and regional and international organisations relating to military and defence matters.

(2)

The northern regions of the coastal countries of the Gulf of Guinea, namely Ghana, Côte d’Ivoire, Benin and Togo, have been experiencing deteriorating security conditions in connection with the crisis affecting the central Sahel.

(3)

In light of the deteriorating security environment, it is important to strengthen the defence and security forces to enable and support stabilisation efforts in Ghana. In this context, and fully cognisant of the fact that the situation requires an integrated response, long-term peace and security in Ghana are a key priority for the Union.

(4)

On 5 May 2023, the High Representative of the Union for Foreign Affairs and Security Policy received a request from Ghana for the Union to assist the Ghana Armed Forces with the procurement of key equipment to strengthen the operational capabilities of the military units deployed in the northern part of the country to fight armed groups and counteract and reduce the opportunities for those groups to commit terrorist attacks.

(5)

Assistance measures are to be implemented taking into account the principles and requirements set out in Decision (CFSP) 2021/509, in particular compliance with Council Common Position 2008/944/CFSP (2), and in accordance with the rules for the implementation of revenue and expenditure financed under the EPF.

(6)

The Council reaffirms its determination to protect, promote and fulfil human rights, fundamental freedoms and democratic principles and to strengthen the rule of law and good governance, in compliance with the United Nations Charter, the Universal Declaration of Human Rights and international law, in particular international human rights law and international humanitarian law,